Xifyrm Approved for Management of Moderate to Severe Pain

The Food and Drug Administration (FDA) has approved Xifyrm^™ (meloxicam injection) for use in adults for the management of moderate to severe pain, alone or in combination with non-NSAID (non-steroidal anti-inflammatory) analgesics. 

Meloxicam, an NSAID, works by inhibiting cyclooxygenase 1 and 2, leading to analgesic, anti-inflammatory, and antipyretic effects. The approval of Xifyrm was based on established efficacy data involving meloxicam injection in postoperative pain (ClinicalTrials.gov Identifiers: NCT02675907; NCT02678286).

Xifyrm is supplied as a single-dose vial containing 30mg of meloxicam per mL. The recommended dose is 30mg once daily administered by intravenous bolus injection over 15 seconds. 

Patients who receive Xifyrm should be monitored for analgesic response. Because of delayed onset of analgesia (median time to meaningful pain relief: 2-3 hours), Xifyrm alone is not recommended when rapid onset of effect is needed. If response is inadequate, a short-acting, non-NSAID, immediate-release analgesic may be administered.  

As with other NSAIDs, the prescribing information for Xifyrm includes a Boxed Warning for the risk of serious cardiovascular and gastrointestinal events. The most common adverse reactions reported with meloxicam injection were constipation, increased gamma-glutamyl transferase, and anemia. Additionally, patients should be well hydrated prior to administration to reduce the risk of renal toxicity.

“Xifyrm demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management,” said Ron Scarboro, CEO at Azurity Pharmaceuticals. “Xifyrm addresses an important clinical need, especially for patients requiring a non-opioid component to multimodal analgesia strategies.”

According to Azurity Pharmaceuticals, Xifyrm will be available in the coming weeks.

This article originally appeared on MPR